The University of Arizona

Giner, Inc.

Giner Life Sciences, Inc.

Procyon Technologies LLC

Wilson Wolf Manufacturing Corporation

Klearchos K Papas

Simon G Stone

Linda A Tempelman

John R Wilson

Daniel P Welch

Joana Ferrer Fabrega

Michael D Rizzari

William Earl Scott, Iii

Thomas M Suszynski

Shuichiro Matsumoto

Efstathios S Avgoustiniatos

An encapsulation device system for therapeutic applications such as but not limited to regulating blood glucose. The system may comprise an encapsulation device with a first oxygen sensor integrated inside the device and a second oxygen sensor disposed on an outer surface of the device, wherein the sensors allow for real-time measurements (such as oxygen levels) related to cells (e.g., islet cells, stem cell derived beta cells, etc.) housed in the encapsulation device. The system may also feature an exogenous oxygen delivery system operatively connected to the encapsulation device via a channel, wherein the exogenous oxygen delivery system is adapted to deliver oxygen to the encapsulation device.

Encapsulation device systems with oxygen sensors with or without exogenous oxygen delivery

Methods and systems for measuring viability and function of islet cells or stem cell-derived beta cells in an implantable device featuring setting the temperature of the cells in the implantable device to a low temperature to reduce metabolic levels of the cells and reduce oxygen requirements of the cells, and measuring oxygen consumption rates. An oxygen sensor at the inlet of the implantable device and an oxygen sensor at the outlet of the implantable device are used to calculate oxygen consumption rates of the cells, which in turn are indicative of viability. The reduction in temperature can also be used for loading cells into the implantable devices to help reduce ischemic and/or physical injury. The present invention may be used with other cell types, e.g. hepatocytes, heart cells, muscle cells, etc.

Methods and systems for real-time assessment of cells in encapsulation devices pre-and post-transplantation

Embodiments of the present disclosure relate to encapsulation devices, systems and methods of use. In some embodiments, encapsulation devices for housing cells and providing various therapeutic benefits to a patient or host are described. Encapsulation devices include, for example, a matrix or scaffold within a cell-receiving area or void. Encapsulation devices may include channels that are operable to convey fluid to internal areas of devices without restricting vascularization.

Methods and systems for encapsulation devices for housing cells and agents

System for gas treatment of cellular implants. The system enhances the viability and function of cellular implants, particularly those with high cellular density, for use in human or veterinary medicine. The system utilizes a miniaturized electrochemical gas generator subsystem that continuously supplies oxygen and/or hydrogen to cells within an implantable and immunoisolated cell containment subsystem to facilitate cell viability and function at high cellular density while minimizing overall implant size. The cell containment subsystem is equipped with features to allow gas delivery through porous tubing or gas-only permeable internal gas compartments within the implantable cell containment subsystem. Furthermore, the gas generator subsystem includes components that allow access to water for electrolysis while implanted, thereby promoting long-term implantability of the gas generator subsystem. An application of the system is a pancreatic islet (or pancreatic islet analogue) implant for treatment of Type 1 diabetes (T1D) that would be considered a bio-artificial pancreas.

System for gas treatment of a cell implant

Systems featuring two or more encapsulation devices stacked together. The encapsulation devices house cells, such as but not limited to islet cells or stem cell derived beta cells or the like. e.g., for regulating blood glucose, or other cells or spheroids that can produce and release a therapeutic agent that is useful in the body, etc. The system may feature oxygen delivery, or in some cases no exogenous oxygen is delivered and vascularization of the device can help provide oxygen and other needed nutrient to the cells. The system of the present invention may be used in conjunction with other therapies such as an artificial pancreas. Stacking the devices with blood vessel formation around and in between them may allow for a decrease in the footprint that would be needed for implantation.

Stacked tissue encapsulation device systems with or without oxygen delivery

Methods, systems, and devices for enhancing cancer immunotherapy featuring co-transplantation of encapsulated xenogeneic cells with separately encapsulated autologous or allogeneic cells, e.g., autologous or allogeneic tumor cells. For example, both a first cellular transplantation device housing a patient's own tumor cells and a second cellular transplantation device housing xenogeneic cells may be implanted into a patient. The presence of the xenogeneic cells elicits an enhanced immune response, e.g., the xenogeneic cells will draw in a large number of immune cells. Shed tumor antigens from the first cellular transplantation may then be taken up by the immune cells that were drawn to the xenogeneic cells. This will generate an anti-tumor immune response that is amplified relative to a response elicited by the encapsulated tumor cells alone.

Methods and systems for augmenting immune system responses

System for gas treatment of cellular implants. The system enhances the viability and function of cellular implants, particularly those with high cellular density, for use in human or veterinary medicine. The system utilizes a miniaturized electrochemical gas generator subsystem that continuously supplies oxygen and/or hydrogen to cells within an implantable and immunoisolated cell containment subsystem to facilitate cell viability and function at high cellular density while minimizing overall implant size. The cell containment subsystem is equipped with features to allow gas delivery through porous tubing or gas-only permeable internal gas compartments within the implantable cell containment subsystem. Furthermore, the gas generator subsystem includes components that allow access to water for electrolysis while implanted, thereby promoting long-term implantability of the gas generator subsystem. An application of the system is a pancreatic islet (or pancreatic islet analog) implant for treatment of Type 1 diabetes (T1D) that would be considered a bio-artificial pancreas.

Method and system for organ preservation. According to one aspect, an organ may be preserved by being perfused with an in situ generated preserving gas. The organ may be, for example, a human or porcine pancreas, and perfusion of the pancreas may be anterograde, retrograde, ductal, anterograde/ductal, or retrograde/ductal. The preserving gas used to perfuse the organ may be dissolved in a liquid and then administered to the organ as a gas/liquid solution or may be mixed with one or more other gases and then administered to the organ as a gas/gas mixture. The preserving gas may be, for example, oxygen gas generated in situ using an electrochemical oxygen concentrator. According to another aspect, an organ preservation system may include an electrochemical oxygen concentrator having a water vapor feed, as well as auxiliary equipment to control and measure delivery pressure, flow, temperature and humidity.

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Tucson, AZ, United States of America

Klearchos K Papas